(104 days)
The Multiple Instrument Guide (MIG) is used for surgical instrument and choledochoscope access into the common bile duct during laparoscopic common bile duct exploration (LCBDE).
The Multiple Instrument Guide ("MIG") is a three-lumen plastic extension that has a curved J-tip configuration. The MIG in its entirety is 13 inches in length. The largest lumen is 3.4mm in diameter and will allow the passage of a choledochoscope through it. The other two lumens are 1.8mm and 2.0mm in diameter. The MIG itself is composed entirely of polyethylene. The sheath which aids the introduction of the MIG into the patient is composed of a clear rigid, non-toxic vinyl compound developed especially for the medical industry. The sheath is 8.0 inches in length, a hollow end diameter of .320 inches, and a wall thickness of .035 inches. It is a simple hollow tube in which the MIG is passed through, into the patient. The MIG is also accompanied by a small plug (which does not come into contact with the patient) to prevent leaking of the carbon dioxide used in laparoscopic procedures. The plug is composed of polyethylene, is .069 inches in diameter, and is 1.5 inches long. The MIG requires no form of electrical or battery power, it is operated manually by a laparoscopic surgeon. The MIG, sheath, and plug are all sterile, single use items. The MIG is coated with a Hydromer, Inc. hydrophilic coating which becomes lubricious when activated with water. Its purpose is to reduce friction when the MIG enters the sheath and the patient. The coating is a completely inert, non-leeching, non-extractable material. It alleviates the need for the physician to use other water-based lubricants, because it is permanently coated onto each MIG.
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device called the "Lap Surgical Systems Multiple Instrument Guide" (MIG). It primarily discusses the device's substantial equivalence to a predicate device and its intended use.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance. While it describes the device's function and composition, there are no specific performance metrics or acceptance criteria mentioned.
- Details about a study that proves the device meets acceptance criteria. There's no mention of any clinical or performance study, sample sizes, data provenance, ground truth establishment, or expert reviews.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance. The device is a physical instrument, not an AI or software-based system, so these types of studies are not applicable.
- Any discussion of ground truth.
- Sample size for training sets. Again, this is a physical device, not an AI model.
The document is a regulatory filing focused on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed study results.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.